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Trinity Biotech

FDA UDI

Class II (US FDA UDI)

by Mardx Diagnostics, Inc.

Identity

Trade Name
Trinity Biotech FDA UDI
Generic Name
Borrelia burgdorferi antigen IVD, reagent FDA UDI
Device Name
Alkaline Phosphatase Conjugate, Anti-Human IgG, 11mL FDA UDI
Model / Reference
40-2525G FDA UDI
Description
Alkaline Phosphatase Conjugate, Anti-Human IgG, 11mL FDA UDI

Identifiers

Catalog Number
40-2525G FDA UDI
Primary DI / UDI-DI
05391516747660 FDA UDI
510(k) Number
K950829 FDA UDI
FDA Product Code
LSR FDA UDI
GMDN Term
Borrelia burgdorferi antigen IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3830 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Borrelia burgdorferi antigen IVD, reagent

Trinity Biotech by Mardx Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Borrelia burgdorferi antigen IVD, reagent.

Cleared under the same submission

K950829 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mardx Diagnostics, Inc.

Sources (1)

  • FDA UDI f6036474-42d3-4a82-bd47-bcc5d3d38a8c 37 fields · synced May 30, 2026